83_FR_46675 83 FR 46497 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

83 FR 46497 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 178 (September 13, 2018)

Page Range46497-46498
FR Document2018-19906

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.

Federal Register, Volume 83 Issue 178 (Thursday, September 13, 2018) 
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46497-46498]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3381]


Science Board to the Food and Drug Administration Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

[[Page 46498]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Science Board to the Food and 
Drug Administration. The Science Board provides advice to the 
Commissioner of Food and Drugs and other appropriate officials on 
specific, complex scientific and technical issues important to FDA and 
its mission, including emerging issues within the scientific community. 
Additionally, the Science Board provides advice to the Agency on 
keeping pace with technical and scientific developments including in 
regulatory science, input into the Agency's research agenda, and on 
upgrading its scientific and research facilities and training 
opportunities. It will also provide, where requested, expert review of 
Agency sponsored intramural and extramural scientific research 
programs. The meeting will be open to the public.

DATES: The meeting will be held on October 22, 2018, from 8:30 a.m. to 
4:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, 
MD 20993. For those unable to attend in person, the meeting will also 
be webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard2018/. Answers to commonly asked 
questions including information regarding special accommodations due to 
a disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver 
Spring, MD 20993, 301-796-4769, [email protected], or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area). A notice in the Federal Register about last 
minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the Agency's website 
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down 
to the appropriate advisory committee meeting link, or call the 
advisory committee information line to learn about possible 
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The Science Board will hear a response from the Center for 
Veterinary Medicine (CVM) to the recommendations made by the Science 
Board's 2017 review of CVM's National Antibiotic Resistance Monitoring 
System program. The Science Board will also discuss potential hazards 
and nutritional considerations in the production of food derived from 
animal cell culture technologies.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
October 15, 2018. Oral presentations from the public will be scheduled 
between approximately 3:30 p.m. and 4:30 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before October 5, 2018. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by October 9, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Rakesh Raghuwanshi at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19906 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices 46497 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Number of responses Total annual Average 21 CFR section; activity Total hours respondents per responses burden per response respondent 507.67, 507.69, and 507.71; submission of an appeal, including submission of 1 1 1 4 ...................................... 4 a request for an informal hearing. 507.85(b); requests for reinstatement of exemption ........................................... 1 1 1 2 ...................................... 2 Total .............................................................................................................. .................... .................... .................... ......................................... 286 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Number of Average records per Total annual 21 CFR section; activity record- burden per Total hours record- records keepers recordkeeping keeper Subpart A—General Provisions 507.7(e); records attesting that the facility is a ‘‘qualified’’ facility ...................... 1,120 0.5 560 0.1 (6 minutes) ............... 56 507.4(d); documentation of animal food safety and hygiene training ................. 7,469 0.75 5,579 0.05 (3 minutes) ............. 279 Subpart C—Hazard Analysis and Risk-Based Preventive Controls 507.31 through 507.55; food safety plan—including hazard analysis, preven- 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641 tive controls, monitoring, corrective actions, verification, validation reanaly- sis, modifications, and implementation records. Subpart E—Supply-Chain Program 507.105 through 507.175; written supply-chain program—including records 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641 documenting program. Subpart F—Requirements Applying to Records 507.200 through 507.215; general requirements, additional requirements ap- 7,469 519 3,876,411 0.1 (6 minutes) ............... 387,641 plying to food safety plan, requirements for record retention, use of existing records, and special requirements applicable to written assurance. Totals ............................................................................................................ .................... .................... 11,635,372 ......................................... 1,163,258 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Number of disclosures Total annual Average 21 CFR section; activity Total hours respondents per disclosures burden per disclosure respondent 507.27(b); labeling for the animal food product contains the specific informa- 330 10 3,300 0.25 (15 minutes) ........... 825 tion and instructions needed so the food can be safely used for the intended animal species. 507.7(e)(1); change labels on products with labels ............................................ 1,526 4 6,104 1 ...................................... 6,104 507.7(e)(2); change address on labeling (sales documents) for qualified facili- 1,329 1 1,329 1 ...................................... 1,329 ties. 507.25(a)(2); animal food, including raw materials, other ingredients, and re- 330 312 102,960 0.01 (36 seconds) .......... 1,030 work, is accurately identified. 507.28(b); holding and distribution of human food byproducts for use as ani- 40,798 2 81,596 0.25 (15 minutes) ........... 20,399 mal food. Total .............................................................................................................. .................... .................... .................... ......................................... 29,687 1 There are no capital costs or operating and maintenance costs associated with this collection of information. As previously stated, we retain the the time necessary for the individual DEPARTMENT OF HEALTH AND currently approved burden estimate for reporting, recordkeeping, and third- HUMAN SERVICES the information collection. These figures party disclosure activities on our are based on our regulatory impact experience with similar information Food and Drug Administration analysis in support of the final rule on collections. daltland on DSKBBV9HB2PROD with NOTICES Preventive Controls for Food for [Docket No. FDA–2018–N–3381] Dated: September 7, 2018. Animals, which published in the Leslie Kux, Science Board to the Food and Drug Federal Register of September 17, 2015 Associate Commissioner for Policy. Administration Advisory Committee; (80 FR 56170). Using Agency data, we [FR Doc. 2018–19909 Filed 9–12–18; 8:45 am] Notice of Meeting estimated the number of animal food facilities that we believe are subject to BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, the regulations. We base our estimate of HHS. VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1

46498 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices ACTION: Notice. modifications before coming to the disability, please contact Rakesh meeting. Raghuwanshi at least 7 days in advance SUMMARY: The Food and Drug of the meeting. Administration (FDA) announces a SUPPLEMENTARY INFORMATION: Agenda: The Science Board will hear FDA is committed to the orderly forthcoming public advisory committee conduct of its advisory committee meeting of the Science Board to the a response from the Center for Veterinary Medicine (CVM) to the meetings. Please visit our website at Food and Drug Administration. The https://www.fda.gov/Advisory Science Board provides advice to the recommendations made by the Science Board’s 2017 review of CVM’s National Committees/AboutAdvisoryCommittees/ Commissioner of Food and Drugs and ucm111462.htm for procedures on other appropriate officials on specific, Antibiotic Resistance Monitoring System program. The Science Board public conduct during advisory complex scientific and technical issues committee meetings. important to FDA and its mission, will also discuss potential hazards and nutritional considerations in the Notice of this meeting is given under including emerging issues within the the Federal Advisory Committee Act (5 scientific community. Additionally, the production of food derived from animal cell culture technologies. U.S.C. app. 2). Science Board provides advice to the Agency on keeping pace with technical FDA intends to make background Dated: September 10, 2018. and scientific developments including material available to the public no later Leslie Kux, in regulatory science, input into the than 2 business days before the meeting. Associate Commissioner for Policy. Agency’s research agenda, and on If FDA is unable to post the background [FR Doc. 2018–19906 Filed 9–12–18; 8:45 am] upgrading its scientific and research material on its website prior to the BILLING CODE 4164–01–P facilities and training opportunities. It meeting, the background material will will also provide, where requested, be made publicly available at the expert review of Agency sponsored location of the advisory committee DEPARTMENT OF HEALTH AND intramural and extramural scientific meeting, and the background material HUMAN SERVICES research programs. The meeting will be will be posted on FDA’s website after open to the public. the meeting. Background material is Food and Drug Administration available at https://www.fda.gov/ [Docket No. FDA–2016–N–1984] DATES: The meeting will be held on AdvisoryCommittees/Calendar/ October 22, 2018, from 8:30 a.m. to 4:30 default.htm. Scroll down to the p.m. Request for Nominations on the appropriate advisory committee meeting Tobacco Products Scientific Advisory ADDRESSES: FDA White Oak Campus, link. Committee 10903 New Hampshire Ave., Bldg. 31 Procedure: Interested persons may Conference Center, the Great Room (Rm. present data, information, or views, AGENCY: Food and Drug Administration, 1503, section A), Silver Spring, MD orally or in writing, on issues pending HHS. 20993. For those unable to attend in before the committee. Written ACTION: Notice. person, the meeting will also be submissions may be made to the contact webcast. The link for the webcast is person on or before October 15, 2018. SUMMARY: The Food and Drug available at https://collaboration. Oral presentations from the public will Administration (FDA or Agency) is fda.gov/scienceboard2018/. Answers to be scheduled between approximately requesting that any small business commonly asked questions including 3:30 p.m. and 4:30 p.m. Those tobacco manufacturing industry information regarding special individuals interested in making formal organizations interested in participating accommodations due to a disability, oral presentations should notify the in the selection of a nonvoting industry visitor parking, and transportation may contact person and submit a brief representative to serve on the Tobacco be accessed at: https://www.fda.gov/ statement of the general nature of the Products Scientific Advisory Committee AdvisoryCommittees/AboutAdvisory evidence or arguments they wish to for the Center for Tobacco Products Committees/ucm408555.htm. present, the names and addresses of notify FDA in writing. FDA is also FOR FURTHER INFORMATION CONTACT: proposed participants, and an requesting nominations for nonvoting Rakesh Raghuwanshi, Office of the indication of the approximate time industry representatives to be included Chief Scientist, Office of the requested to make their presentation on in a pool of individuals to represent the Commissioner, Food and Drug or before October 5, 2018. Time allotted interests of the small business tobacco Administration, 10903 New Hampshire for each presentation may be limited. If manufacturing industry on the Tobacco Ave., Bldg. 1, Rm. 3309, Silver Spring, the number of registrants requesting to Products Scientific Advisory MD 20993, 301–796–4769, speak is greater than can be reasonably Committee. A nominee may either be rakesh.raghuwanshi@fda.hhs.gov, or accommodated during the scheduled self-nominated or nominated by an FDA Advisory Committee Information open public hearing session, FDA may organization to serve as a nonvoting Line, 1–800–741–8138 (301–443–0572 conduct a lottery to determine the industry representative. This position in the Washington, DC area). A notice in speakers for the scheduled open public may be filled on a rotating, sequential the Federal Register about last minute hearing session. The contact person will basis by representatives of different modifications that impact a previously notify interested persons regarding their small business tobacco manufacturers announced advisory committee meeting request to speak by October 9, 2018. based on areas of expertise relevant to cannot always be published quickly Persons attending FDA’s advisory the topics being considered by the enough to provide timely notice. committee meetings are advised that the Advisory Committee. Nominations will daltland on DSKBBV9HB2PROD with NOTICES Therefore, you should always check the Agency is not responsible for providing be accepted for current vacancies Agency’s website at https:// access to electrical outlets. effective with this notice. www.fda.gov/AdvisoryCommittees/ FDA welcomes the attendance of the DATES: Any small business tobacco default.htm and scroll down to the public at its advisory committee manufacturing industry organization appropriate advisory committee meeting meetings and will make every effort to interested in participating in the link, or call the advisory committee accommodate persons with disabilities. selection of appropriate nonvoting information line to learn about possible If you require accommodations due to a members to represent industry interests VerDate Sep<11>2014 19:20 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\13SEN1.SGM 13SEN1


Document Created: 2018-09-13 01:02:00
Document Modified: 2018-09-13 01:02:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on October 22, 2018, from 8:30 a.m. to 4:30 p.m.
ContactRakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301-796-4769, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation83 FR 46497 
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